Researchers at the University Hospital Hamburg-Eppendorf (UKE) are investigating whether over-the-counter cold remedies with the active ingredient pseudoephedrine can trigger heart attacks or other serious cardiovascular events in certain people. Individual case reports give rise to this suspicion. The study, funded by the German Heart Foundation, is intended to clarify whether and under what conditions such preparations could be dangerous.

In recent years, isolated cases have been documented in which previously healthy, often young people suffered heart attacks or strokes after taking pseudoephedrine-containing cold medicines such as Aspirin Complex or Grippostad Complex. However, previous epidemiological studies have not been able to find clear evidence of an increased risk of cardiovascular problems due to pseudoephedrine. A research team led by Prof. Dr. Thomas Eschenhagen, Director of the Institute of Experimental Pharmacology and Toxicology at the UKE, now wants to clarify this contradiction.

Eschenhagen became aware of the topic when, as an expert for the Drug Commission of the German Medical Association , he examined the tragic case of a 42-year-old man. He had suffered a severe heart attack only 30 minutes after taking a single sachet of the cold remedy Aspirin Complex, from which he died a few days later. The man had no cardiovascular problems before. However, the angiogram (X-ray) after the infarction showed diffuse spasms (cramps) of the coronary arteries.
“This case was the occasion for me to deal more intensively with the matter,” reports Prof. Eschenhagen. “Similar case reports have been found in the literature for years, often in previously completely inconspicuous, often young people.” As a pharmacologist, the connection between coronary spasms and the intake of pseudoephedrine is completely plausible for him: “Pseudoephedrine is an indirect sympathomimetic that leads to the release of the neurotransmitter norepinephrine – incidentally similar to amphetamines, such as ecstasy or cocaine,” he explains.

The German Heart Foundation is supporting the project with 77,500 euros. The aim is to better understand possible risks and identify people who are particularly at risk. A tragic case in which a 42-year-old man suffered a fatal heart attack after taking a cold remedy brought the issue into focus. Examinations showed that the man had no heart problems before, but had diffuse spasms of the coronary arteries.

Pseudoephedrine, an active ingredient in at least 15 over-the-counter cold remedies, has a vasoconstrictive and decongestant effect on colds. At the same time, it has a stimulating effect, similar to certain stimulants, which explains its popularity. It is estimated that such preparations are taken hundreds of thousands of times in Germany during a cold season.

Because severe side effects are very rare, the researchers suspect that a rare genetic predisposition makes some people more susceptible. In order to investigate this, the UKE has been asking heart attack patients specifically about taking cold medicines for several months. A special questionnaire has been developed to record such cases. In addition, blood from heart attack patients in recent years will be tested for pseudoephedrine and compared with a control group.

The scientists hope to identify at least 20 cases with severe side effects to find possible genetic causes. Even with fewer cases, initial findings about genetic risk factors could be gained. In the long term, a genetic test could help warn people at risk against taking such drugs.

As an alternative, Eschenhagen recommends active ingredients such as ASA, ibuprofen or paracetamol to relieve cold symptoms as well as nasal sprays with oxy- or xylometazoline. He is critical of the stimulating effect of pseudoephedrine, as it could delay recovery and, in rare cases, promote serious complications such as myocarditis.

Sources and further information:

• Federal Institute for Drugs and Medical Devices (BfArM) April 10, 2024 https://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RV_STP/m-r/pseudoephedrin.html?nn=471274
  
• BfArM February 14, 2019 https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/Pharmakovigilanz/PSUSAS/m-r/pseudoephedrin-acetylsalicylsaeure_beschluss_cmdh_Anl4.pdf?__blob=publicationFile
  
• Drug Commission of the German Medical Association December 17, 2024 https://www.akdae.de/arzneimittelsicherheit/drug-safety-mail/newsdetail/drug-safety-mail-2024-52

Editor: X-Press Journalistenbüro GbR

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